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Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing.
Int J Pharm. 2017 Jul 15; 527(1-2):21-30.IJ

Abstract

The aim of this study was to manufacture 3D printed tablets (printlets) from enteric polymers by single filament fused deposition modeling (FDM) 3D printing (3DP). Hot melt extrusion was used to generate paracetamol-loaded filaments from three different grades of the pharmaceutical excipient hypromellose acetate succinate (HPMCAS), grades LG, MG and HG. One-step 3DP was used to process these filaments into enteric printlets incorporating up to 50% drug loading with two different infill percentages (20 and 100%). X-ray Micro Computed Tomography (Micro-CT) analysis revealed that printlets with 20% infill had cavities in the core compared to 100% infill, and that the density of the 50% drug loading printlets was higher than the equivalent formulations loaded with 5% drug. In biorelevant bicarbonate dissolution media, drug release from the printlets was dependent on the polymer composition, drug loading and the internal structure of the formulations. All HPMCAS-based printlets showed delayed drug release properties, and in the intestinal conditions, drug release was faster from the printlets prepared with polymers with a lower pH-threshold: HPMCAS LG > HPMCAS MG > HPMCAS HG. These results confirm that FDM 3D printing makes it possible not only to manufacture delayed release printlets without the need for an outer enteric coating, but it is also feasible to adapt the release profile in response to the personal characteristics of the patient, realizing the full potential of additive manufacturing in the development of personalised dose medicines.

Authors+Show Affiliations

FabRx Ltd., 3 Romney Road, Ashford, Kent, TN24 0RW, UK.UCL School of Pharmacy, University College London,29-39 Brunswick Square, London, WC1N 1AX, UK.UCL School of Pharmacy, University College London,29-39 Brunswick Square, London, WC1N 1AX, UK.UCL School of Pharmacy, University College London,29-39 Brunswick Square, London, WC1N 1AX, UK.FabRx Ltd., 3 Romney Road, Ashford, Kent, TN24 0RW, UK; UCL School of Pharmacy, University College London,29-39 Brunswick Square, London, WC1N 1AX, UK.FabRx Ltd., 3 Romney Road, Ashford, Kent, TN24 0RW, UK; UCL School of Pharmacy, University College London,29-39 Brunswick Square, London, WC1N 1AX, UK. Electronic address: a.basit@ucl.ac.uk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28502898

Citation

Goyanes, Alvaro, et al. "Development of Modified Release 3D Printed Tablets (printlets) With Pharmaceutical Excipients Using Additive Manufacturing." International Journal of Pharmaceutics, vol. 527, no. 1-2, 2017, pp. 21-30.
Goyanes A, Fina F, Martorana A, et al. Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing. Int J Pharm. 2017;527(1-2):21-30.
Goyanes, A., Fina, F., Martorana, A., Sedough, D., Gaisford, S., & Basit, A. W. (2017). Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing. International Journal of Pharmaceutics, 527(1-2), 21-30. https://doi.org/10.1016/j.ijpharm.2017.05.021
Goyanes A, et al. Development of Modified Release 3D Printed Tablets (printlets) With Pharmaceutical Excipients Using Additive Manufacturing. Int J Pharm. 2017 Jul 15;527(1-2):21-30. PubMed PMID: 28502898.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing. AU - Goyanes,Alvaro, AU - Fina,Fabrizio, AU - Martorana,Annalisa, AU - Sedough,Daniel, AU - Gaisford,Simon, AU - Basit,Abdul W, Y1 - 2017/05/11/ PY - 2017/03/28/received PY - 2017/05/07/revised PY - 2017/05/09/accepted PY - 2017/5/16/pubmed PY - 2018/1/6/medline PY - 2017/5/16/entrez KW - Acetaminophen KW - Additive manufacture KW - Additive manufacturing KW - Controlled-release KW - Fused deposition modeling KW - Paracetamol KW - Personalized medicines KW - Rapid prototyping KW - Three dimensional printing SP - 21 EP - 30 JF - International journal of pharmaceutics JO - Int J Pharm VL - 527 IS - 1-2 N2 - The aim of this study was to manufacture 3D printed tablets (printlets) from enteric polymers by single filament fused deposition modeling (FDM) 3D printing (3DP). Hot melt extrusion was used to generate paracetamol-loaded filaments from three different grades of the pharmaceutical excipient hypromellose acetate succinate (HPMCAS), grades LG, MG and HG. One-step 3DP was used to process these filaments into enteric printlets incorporating up to 50% drug loading with two different infill percentages (20 and 100%). X-ray Micro Computed Tomography (Micro-CT) analysis revealed that printlets with 20% infill had cavities in the core compared to 100% infill, and that the density of the 50% drug loading printlets was higher than the equivalent formulations loaded with 5% drug. In biorelevant bicarbonate dissolution media, drug release from the printlets was dependent on the polymer composition, drug loading and the internal structure of the formulations. All HPMCAS-based printlets showed delayed drug release properties, and in the intestinal conditions, drug release was faster from the printlets prepared with polymers with a lower pH-threshold: HPMCAS LG > HPMCAS MG > HPMCAS HG. These results confirm that FDM 3D printing makes it possible not only to manufacture delayed release printlets without the need for an outer enteric coating, but it is also feasible to adapt the release profile in response to the personal characteristics of the patient, realizing the full potential of additive manufacturing in the development of personalised dose medicines. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/28502898/Development_of_modified_release_3D_printed_tablets__printlets__with_pharmaceutical_excipients_using_additive_manufacturing_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)30431-3 DB - PRIME DP - Unbound Medicine ER -